# K081042: Microthermx-100 Microwave Ablation System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Bsd Medical Systems Corp.
- Decided: Sep 3, 2008 after 145 days
- Product code: NEY (System, Ablation, Microwave And Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K861904 (1986). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833158: BSD-200, Bsd Medical Corp. (1984) Summary page 1.
- K950301: Angiocath (R) Nonvalon (R) and Angio-Set (R) IV Catheters, Becton Dickinson Vascular Access, Inc. (1995) Summary page 1.
- K011676: Vivawave Microwave System, Vivant Medical, Inc. (2002) Summary page 1.
- K031556: Vivatherm Themperature Measurement System, Vivant Medical, Inc. (2003) Summary page 1.
- K032702: Vivatip Microwave Ablation Probe, Vivant Medical, Inc. (2003) Summary page 1.
- K040279: Vivaring Microwave Ablation Probe, Vivant Medical, Inc. (2004) Summary page 1.
- K050223: Vivawave Microwave Ablation System, Coaxial Introducer, Vivant Medical, Inc. (2005) Summary page 1.
- K053535: Vivawave Microwave Ablation System, Valleylab (2006) Summary page 1.

## Most influential descendants
- K100786: Microthermx Microwave Ablation System, Models MTX-180 or MTX (2010), 1 descendant of its own
- K141785: Micro Thermx Microwave Ablation System and Accessories (2015), 0 descendants of its own

## Indications for use
The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The MTX-100 microwave applicators, which are inserted using the provided OTN catheters, may be used in open surgical as well as percutaneous ablation procedures. Optional temperature sensors may be used to monitor tissue temperatures.

Source page: https://510kreport.com/device/K081042
Methodology: https://510kreport.com/methodology